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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected
Recalled February 28, 2024 · FDA recall Z-1144-2024 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Hazard
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure. · FDA Class II
Units
1,993 US; 2,662 OUS
Sold at
Worldwide - US Nationwide distribution.
Description
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →